Neural Magnetic Stimulator D190

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Neural Magnetic Stimulator, the D190

510(k) Number

K883340 ↗

FDA Product Code

GWF

Device Class

Class II

Regulation

21 CFR Part 882.1870

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• The 3500

  Class II

  FDA 510(k) K822396 Active Cleared 24 Sep 1982

• Cdsa(Color Density, Spectral Arrray)

  Class II

  FDA 510(k) K852587 Active Cleared 16 Aug 1985

• Tm-3600 a Neurodiagnostic System

  Class II

  FDA 510(k) K860903 Active Cleared 5 Jun 1986

• Tn-3000 Evoked Response System

  Class II

  FDA 510(k) K810560 Active Cleared 17 Mar 1981

• Guardian, EEG Brain Monitoring System

  Class II

  FDA 510(k) K874733 Active Cleared 29 Feb 1988

• Nomad TM-3400

  Class II

  FDA 510(k) K850109 Active Cleared 4 Jun 1985

See all devices from Tracor Northern, Inc. →

• What is the primary clinical application of the Neural Magnetic Stimulator, D190, and where is it typically used?

  The Neural Magnetic Stimulator, D190, is designed to apply non-invasive magnetic stimulation to the nervous system, inducing electrical currents in targeted neural tissue. This facilitates research and diagnostic assessments of neural pathways and cortical excitability, primarily in neurology. It is intended for use in clinical research and diagnostic settings, such as hospitals or specialized neurology clinics.

• Is the Neural Magnetic Stimulator, D190, a single-use or reusable device, and what does this mean for maintenance?

  The Neural Magnetic Stimulator, D190, is explicitly described as a reusable medical instrument. This means it is built for repeated use in clinical settings, requiring proper cleaning, calibration, and maintenance between procedures to ensure safety and performance. Since it is reusable, it must comply with electrical safety standards and be used in environments that meet those requirements.

• What regulatory pathway was followed for FDA clearance of the Neural Magnetic Stimulator, D190, and what does this imply about its approval status?

  The Neural Magnetic Stimulator, D190, received FDA clearance through a Traditional 510(k) pathway, with a decision code of SESE (Substantially Equivalent) under the advisory committee NE (Neurology). This implies the device was determined to be substantially equivalent to a legally marketed predicate device, meeting FDA requirements for safety and effectiveness. No third-party review was required for this clearance.

• Can the Neural Magnetic Stimulator, D190, be used in an MRI environment, and why?

  No, the Neural Magnetic Stimulator, D190, is not MRI-safe. This is explicitly stated in the device description, meaning it should never be used in an MRI environment due to potential interference with magnetic fields or safety risks to patients and staff. It must only be operated in settings compliant with electrical safety standards.

• How should the Neural Magnetic Stimulator, D190 be stored, and are there any special considerations for its handling?

  While the device data does not specify storage conditions, as a reusable medical instrument, the Neural Magnetic Stimulator, D190, should be stored in a clean, dry environment protected from physical damage, extreme temperatures, and electromagnetic interference. Since it is not sterile and is intended for repeated use, proper cleaning and maintenance protocols must be followed before and after each use to prevent contamination and ensure functionality.